It was written by one of the most renowned doctors and researchers in the country. It is addressed to Stephen Hahn, head of the Food and Drug Administration, for his performance during the COVID-19 pandemic
A stony letter circulates among the physicians and scientists of the United States. Also in the Food and Drug Administration (FDA), the government body that is at the forefront of the fight against the coronavirus pandemic. It was written by the prestigious cardiologist and geneticist Eric Topol, one of the most prolific researchers and disseminators in that country and current Editor-in-Chief of Medscape, one of the most consulted medical science sites in the world. This medium not only publishes news about health but also offers training to professionals in the sector. Such is its importance.
In the last hours, Topol decided to go directly to Stephen Hahn, Commissioner of the FDA for his actions during the COVID-19 outbreak, to whom he suggested that he resign from his position of such responsibility for the health of Americans. Titled “Dear Commissioner Hahn: Tell the Truth or Resign,” Topol drew the lines that rocked the medical world. Next, the epistle:
Dear Dr. Hahn,
I’m writing because I’m gravely concerned about your leadership of the Food and Drug Administration (FDA). The circumstances of your statements in recent days has led to a crisis in confidence. Not only has your credibility been diminished but so has that of the FDA, its 15,000-plus staff members, and, most importantly, your ability to oversee the health interests of the American people.
Let me remind you of the FDA’s mission statement:
“FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.”
The emphasis here is on accurate, science-based information. Since you were sworn in on December 17, 2019, you have serially demonstrated your willingness to deviate from this bedrock premise. Immediately after President Trump widely and aggressively promoted hydroxychloroquine as a “miracle drug,” on March 30, 2020, you granted an Emergency Use Authorization (EUA) for this drug without any sufficient or meaningful supportive evidence. Proof of that was borne out on June 15, 2020 when you revoked that EUA, acknowledging lack of efficacy and “ongoing serious cardiac adverse events and other potential serious side effects.”
The second major breach of accurate, science-based information came on August 23, 2020 when you participated in a press conference with President Trump and Health and Human Services Secretary Alex Azar billed as a “very historic breakthrough.” You said, “I just want to emphasize this point, because I don’t want you to gloss over this number. We dream in drug development of something like a 35% mortality reduction. This is a major advance in the treatment of patients. This is a major advance…[A]nd a 35% improvement in survival is a pretty substantial clinical benefit. What that means is — and if the data continue to pan out — [of] 100 people who are sick with COVID-19, 35 would have been saved because of the admission of plasma.”
Every part of that statement is incorrect and a blatant misrepresentation of the data. Your statement was based on a preprint, which by definition has not been peer-reviewed, published by Mayo Clinic’s Michael Joyner and coauthors. It is a retrospective, observational study of over 35,000 patients who received convalescent plasma, without any controls or untreated patients for comparison. The claim of reduction of mortality is totally unsubstantiated. That was based on improved survival in a subgroup of a subgroup of a subgroup from about 1000 patients, who were partitioned by timing of plasma administration (early vs late), whether they had endotracheal intubation, their age, and level of antibody in the plasma they received. The antibody level was determined post facto. You know full well as an oncologist and researcher that this is an illegitimate analysis that, at best, is hypothesis-generating, requiring a prospective, placebo-controlled trial to confirm.
Nonetheless, you posted this data-dredging subgroup analysis on the FDA website with the headline statement “Another Achievement in Administration’s Fight Against Pandemic.” Your EUA announcement came the day after President Trump tweeted “The deep state, or whoever, over at the FDA is making it very difficult…@SteveFDA“, addressing you directly with your Twitter handle.